Sunday, September 11, 2011

NIH Finalizes Financial Conflict of Interest Rules

The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies.

The rules, which will affect more than 40,000 researchers, come after a string of high profile cases in which federally funded researchers failed to disclose millions of dollars from companies with a financial interest in the outcome of their work.

Researchers who receive more than $5,000 in income from drug or device companies must disclose the payments. Universities or other institutions employing the researchers must collect the data and provide for public access to it.

But in an about-face from proposed rules announced last year, institutions will not be forced to disclose conflict-of-interest information online. (See our prior blog post). Instead, they may maintain the data offline and provide it only when requested.

This change reduces the administrative burden of the proposed public disclosure rule for institutions employing federally funded researchers, said Sally Rockey, the NIH’s deputy director for extramural research.

Universities also will be required to develop plans to manage the financial conflicts of individual researchers, but the plans do not have to be made public.

Praising the “vast majority of researchers” as ethical and sensitive to conflicts of interest, NIH Director Francis S. Collins called the new rules “an insurance plan against potential trouble downstream.”

Collins added that the rules will ensure that government-funded researchers can continue working with private companies.